FDA Approval definition

FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

FDA Approval means the final regulatory approval of the FDA required to commence commercial marketing of a health product.

FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

Examples of FDA Approval in a sentence

• FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1.

• Press release: Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening.

• The statements set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus under the caption “Business — Government Regulation” “FDA Regulation”, FDA Approval or Clearance of Medical Devices, European upon approval insofar as they purport to describe the provisions of the laws, rules, regulations and documents referred to therein, are accurate and complete in all material respects.

• Should either Flexion or Patheon exercise its right to terminate this Agreement or the Manufacturing and Supply Agreement in its entirety (but not in the event of an expiration of this Agreement as set forth in Section 8.2) prior to the FDA Approval Date, then the Manufacturing and Supply Agreement, this Agreement and the Quality Agreement will concurrently and automatically terminate.

• Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA Approval for the commercial manufacture of the Drug Product as quickly as reasonably possible.

More Definitions of FDA Approval

FDA Approval means the approval of the new drug application (NDA) for the Finished Product by the Food and Drug Administration in the United States of America (FDA).

FDA Approval means clearance for marketing by the FDA under Section 510(k) of the Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E, or FDA premarket approval granted in accordance with 21 U.S.C. § 360e and 21 C.F.R. Part 814.

FDA Approval means the FDA approval under 42 U.S.C. § 262(k) of a biologics license application (BLA) authorizing the manufacture and introduction or delivery for introduction into interstate commerce of AVT02 in the United States by the Issuer (or as relevant, any member of the Group), granted to the Issuer (or as relevant, any member of the Group) by FDA of the United States; and for the avoidance of doubt, such an FDA Approval does not include an accelerated approval permitted under 21 U.S.C. 356(c) and 21 C.F.R. part 601, subpart E;

FDA Approval means written receipt from the FDA of approval for marketing a Product in the United States with an approved label including an indication for the Opioid Overdose Indication.

FDA Approval means the receipt by Medtronic of all approvals by the FDA necessary or required for the commercialization in the United States of a Royalty Product.

FDA Approval means the receipt of all Regulatory Approvals from the FDA that would permit Licensor to sell the Licensed Products in the United States for applications within the Field of Use.

FDA Approval means the issuance by the FDA of a biologics license or a supplement to an existing biologics license for a product.